Products

CSF Leakage at the skull base is an occupational hazard for neurosurgeon and otolaryngologist alike. Now Cook Medical has introduced a naturally sourced dural substitute that it claims hits the spot in resolving the troublesome condition.

Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.

Cardica, Inc. is a relative minnow in the world of minimally invasive surgical stapling devices. Now however it has announced two significant new FDA clearances that may well help it to compete with its rather bigger adversaries.

Integra LifeSciences Holdings Corporation has announced the FDA 510(k) clearance and commercial introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle.

Arthroscopy as a surgical discipline continues to grow. A new report says how and why, but we’re left wondering whether we need yet another company to tell us that we’re all getting older so need more of these subcritical procedures. It all sounds a bit obvious if the PR fluff is an example of what’s in the report.

Surgical patients can suffer nerve impairment due to so-called “positioning effect”. Now SafeOp Surgical’s newly FDA cleared system uses neurological monitoring to flag up potential peripheral nerve damage.

Paragonix Inc has big ideas about extending transit and storage time for donor hearts. For now though it’s satisfied with a new FDA clearance that sees its Sherpa Pak system good to enter the market for use within current guidelines.

Contact force-sensing has become something of a buzz word in cardiac ablation as the benefits of being able to avoid too much or too little contact become apparent. Now Biosense Webster has become the first to get its contact force sensing catheter FDA approved.

Orthobiologics company BioStructures, LLC, has seen its Signafuse™ Bioactive Bone Graft Putty granted U.S.FDA 510(k) clearance. Signafuse™ is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine.

Medical device integration solutions company Capsule Tech, Inc., is using the HIMSS event in Florida this week to announce the introduction of its SmartLinx™ Medical Device Information System.

Varicose Vein treatments typify the adoption of new technologies, factors such as economics, reimbursement and clinical resistance all playing their part in ensuring that the old ways, while in decline, will endure for a while yet.

Last year it gained CE mark approval for it’s MIS non-pedicle screw spinal fusion system. Now Aurora Spine has gained Australia’s green light in the form of a TGA clearance to market the device.

It’s been pretty quite in Renal Denervation territory since the January bombshell of Symplicity HTN-3 clinical outcomes. Nonetheless, one company, Cordis, has pushed ahead with its CE marking and now been granted its EU approval.

Stryker is trumpeting the global launch of its new Trevo® XP ProVue Retriever, expanding its line of stent-based clot retrieval devices with additional shapes and sizes.

Cyberonics, Inc. has gained CE Mark approval for its AspireSR generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.

Parametric Sound Corporation, a leading innovator of audio products and solutions, has received U.S. FDA clearance for the marketing of its HyperSound® Audio System as a hearing improvement device.